DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments and amendments filed on 12/22/2025 have been entered.
Claims 1, 4, 6, 7 and 90 have been amended.
In view of Applicant’s amendments to claim 7 the objection is withdrawn.
In view of Applicant’s amendments to claim 90 the 101 rejection is withdrawn.
In view of Applicant’s amendments to claim 6, the new matter rejection is withdrawn.
In view of Applicant’s amendments to claims 1 and 4, the 112(b) rejections are withdrawn.
The 102 rejection has been amended in view of Applicant’s amendment to claim 1.
Claims 1-8, 10 and 90 are examined in the instant application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 8, 10 and 90 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dalton et al. (US 2016/0186140 A1).
Regarding claims 1-5 and 90, Dalton et al. teach a method of differentiating human ES or iPS cells into middle primitive streak cells then into lateral plate mesoderm and then into splanchic mesoderm. Specifically, Dalton teaches contacting lateral plate mesoderm cells with a combination of TGFβ inhibitor, a Wnt inhibitor and activating BMP, FGF and RA signaling pathways to obtain splanchic mesoderm cells (parags. 211, 276, 388 and 416-421).
Regarding the limitation of exhibits decreased expression of PAX3 or PRRX1 relative to middle primitive streak cells, this function would be inherent to the splanchic mesoderm cells of Dalton since Dalton teaches using the same factors and culturing times embraced by the claims.
Regarding claim 7, Dalton teaches contacting lateral plate mesoderm cells with BMP4 and RA (parags. 212 and 419).
Regarding claim 8, Dalton teaches that the period of time is about 36-60 hours (Fig. 62).
Regarding claim 10 and the limitation of increased or decreased expression of markers relative to cardiac mesoderm cells, this function would be inherent to the splanchic mesoderm cells of Dalton since Dalton teaches using the same factors and culturing times embraced by the claims.
Thus the teachings of Dalton clearly anticipate the invention of claims 1-5, 7, 8, 10 and 90.
Response to Arguments
Applicant’s Arguments
Applicants argue in amendment that Dalton does not teach inhibiting or activating every pathway as recited by claim 1 in lateral plate mesoderm cells.
Dalton describes a primary method of deriving ISL+ IMP cells from pluripotent precursors (e.g., embryonic stem cells). This method comprises adding Wnt3a (a Wnt activator) and BMP4 (a BMP activator), alone or in combination with SB421542 (a TGF~ signaling inhibitor) to hESC cultures (see para. [0271]-[0280]. Dalton does not describe adding retinoic acid to hESCs or, by extension, lateral plate mesoderm cells, during the differentiation process. Dalton only teaches using retinoic acid directly on ISL+IMP cells (e.g., Dalton at para. [0358]-[0361]). Dalton explicitly teaches that ISL +IMP cells are formed "from pluripotent stem through a lateral plate mesoderm intermediate followed by transition to a splanchnic mesoderm cell". Therefore, ISL+IMP cells are different than the lateral plate mesoderm intermediate and Dalton's step of applying retinoic acid to ISL +IMP cells is not the same as a step of activating retinoic acid signaling in "lateral plate mesoderm cells" as recited by the instant claims.
Therefore, Dalton does not teach or suggest "activating retinoic acid (RA) signaling in
lateral plate mesoderm cells." Because of this difference, there is no evidence that the cells produced by Dalton are the same as the cells produced by the claimed method. That is, there is no evidence or expectation that cells (e.g., ISL+ IMP) produced by Dalton would inherently possess "decreased expression of PAX3, PRRXl or both relative to middle primitive streak cells".
Examiner’s Response
While Applicant’s arguments have been fully considered they are not found persuasive. As taught in Fig. 62 (reproduced below), Dalton teaches that the time from ESC to lateral plate mesoderm to splanchnic mesoderm can be as little as two days at which point the mixed population of cells are contacted with Wnt3A, BMP4 and RA to produced vascular progenitors. The cells contacted with Wnt3A, BMP4 and RA encompass a mixed population of cells which would also comprise lateral plate mesoderm cells as instantly claimed and thus the teachings of Dalton anticipate the claimed method.
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Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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